Trial · NCT02052310
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
NCT02052310, Phase 3, Completed, Kyntra Bio; results first posted 2021-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants. Trials, record NCT02052310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052310
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
- NCT number
- NCT02052310
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,043 participants, actual
- Lead sponsor
- Kyntra Bio
- Conditions
- Anemia in Incident Dialysis Patients
- Interventions
- Roxadustat, Epoetin Alfa
- First posted
- 2014-02-03
- Last updated
- 2021-10-01
- Other registries' IDs
- eudract:2013-002753-30
- Results first posted
- 2021-10-01
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Baseline (Day 1, Week 0), Week 28 to 52 | Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent \[ESA\]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. |
| Primary | Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) | Baseline (Day 1, Week 0) up to Week 24 | Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb \>8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. |
| Secondary | US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population) | Baseline (Day 1, Week 0) up to Week 24 | Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb \>8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. |
| Secondary | Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population) | Baseline (Day 1, Week 0), Week 28 to 52 | Hb values under the influence of rescue therapy were censored up to 6 weeks in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. |
| Secondary | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24 | Baseline (Day 1, Week 0), Week 12 to 24 | Baseline LDL Cholesterol was defined as the mean of values obtained within 6 weeks prior to the first dose of study treatment. |
| Secondary | Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Week 18 to 24 | Hb values under the influence of rescue therapy were not censored in the analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. |
| Secondary | Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52 | Weeks 28 to 52 | Monthly iron use for each participant = Total IV iron in mg / \[(last dose date - first dose date of study medication in the period)+1\]/ 28. |
| Secondary | Time to First RBC Transfusion | Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa) | Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. |
| Secondary | Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12 | Baseline (Day 1, Week 0), Weeks 8 to 12 | Baseline MAP was defined as the last MAP value prior to the first dose of study treatment. |
| Secondary | Time to First Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | An exacerbation of hypertension was defined as increase from baseline of ≥20 mmHg in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mm Hg in diastolic blood pressure (dBP) and dBP ≥100 mmHg. Median time to event (weeks) was calculated using Kaplan Meier Survival Estimates. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Baseline (Day 1, Week 0), Week 28 to 52 | The ITT population included all randomized participants. | g/dL | MEAN |
| PRIMARY | Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) | Baseline (Day 1, Week 0) up to Week 24 | The per protocol set (PPS) population included all participants in the full analysis set (FAS) population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. | percentage of participants | NUMBER |
| SECONDARY | US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population) | Baseline (Day 1, Week 0) up to Week 24 | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population) | Baseline (Day 1, Week 0), Week 28 to 52 | The PPS population included all participants in the FAS population (all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment) who received at least 8 weeks of treatment and were without major protocol violations. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoint. | g/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 24 | Baseline (Day 1, Week 0), Week 12 to 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Number analyzed' signifies participants with non-missing data for this outcome measure at specified timepoints. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Hb Levels Between Weeks 18 to 24 Regardless of Rescue Therapy in Participants Whose Baseline High Sensitivity C-Reactive Protein (Hs-CRP)> Upper Limit of Normal (ULN) | Baseline (Day 1, Week 0), Week 18 to 24 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | g/dL | MEAN |
| SECONDARY | Median Monthly IV Iron Use Per Patient-Exposure-Month (PEM) During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | mg/PEM | MEDIAN |
| SECONDARY | Time to First RBC Transfusion | Baseline (Day 1, Week 0) up to last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa) | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
| SECONDARY | Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 8 to 12 | Baseline (Day 1, Week 0), Weeks 8 to 12 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Time to First Exacerbation of Hypertension During Weeks 28 to 52 | Weeks 28 to 52 | FAS population included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose Hb assessment. | weeks | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Roxadustat | Baseline | 8.43 | Standard Deviation 1.044 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Epoetin Alfa | Baseline | 8.46 | Standard Deviation 0.964 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Roxadustat | Change at Week 28 to 52 | 2.57 | Standard Deviation 1.269 | g/dL |
| US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) | Epoetin Alfa | Change at Week 28 to 52 | 2.36 | Standard Deviation 1.214 | g/dL |
Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) | Roxadustat | 88.2 | percentage of participants | ||
Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) | Epoetin Alfa | 84.4 | percentage of participants | ||
US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population) | Roxadustat | 84.3 | percentage of participants | ||
US (FDA Submission): Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (ITT Population) | Epoetin Alfa | 79.5 | percentage of participants | ||
| Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population) | Roxadustat | Baseline | 8.43 | Standard Deviation 1.043 | g/dL |
| Ex-US Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (PPS Population) | Epoetin Alfa | Baseline | 8.43 | Standard Deviation 0.963 | g/dL |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 522 | |
| Overall Study | STARTED | Epoetin Alfa | 521 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Roxadustat | 522 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Epoetin Alfa | 517 | |
| Overall Study | COMPLETED | Roxadustat | 307 | |
| Overall Study | COMPLETED | Epoetin Alfa | 309 | |
| Overall Study | NOT COMPLETED | Roxadustat | 215 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 212 |
Source ClinicalTrials.gov
Adverse events834
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Roxadustat | 72 | 522 | |
| other | Diarrhea | Gastrointestinal disorders | Epoetin Alfa | 38 | 517 | |
| other | Nausea | Gastrointestinal disorders | Roxadustat | 45 | 522 | |
| other | Nausea | Gastrointestinal disorders | Epoetin Alfa | 30 | 517 | |
| other | Constipation | Gastrointestinal disorders | Roxadustat | 35 | 522 | |
| other | Constipation | Gastrointestinal disorders | Epoetin Alfa | 23 | 517 | |
| other | Vomiting | Gastrointestinal disorders | Roxadustat | 32 | 522 | |
| other | Vomiting | Gastrointestinal disorders | Epoetin Alfa | 17 | 517 | |
| other | Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | Roxadustat | 26 | 522 | |
| other | Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | Epoetin Alfa | 28 | 517 |
1 to 10 of 834Source ClinicalTrials.gov
See all 834 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 64 | 522 |
| Total, all-cause mortality | Epoetin Alfa | 54 | 517 |
| Total, other adverse events | Roxadustat | 291 | 522 |
| Total, other adverse events | Epoetin Alfa | 262 | 517 |
| Total, serious adverse events | Roxadustat | 234 | 522 |
| Total, serious adverse events | Epoetin Alfa | 218 | 517 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roxadustat vs Epoetin Alfa: deaths from any cause | Trial comparisons |
| Roxadustat vs Epoetin Alfa: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02052310
GET https://conductscience.org/api/trials/v1/NCT02052310/results?page=2